Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial (PRIME-KS)

While tremendous progress has been made against HIV, both in preventing the infection and in treating AIDS, the disease it causes, AIDS-related malignancies like Kaposi sarcoma (KS) remain a significant health burden, in both the U.S. and especially the developing world. In many cases, multiple KS lesions develop simultaneously, and may progress and regress independently. Photographs are an essential part of the evaluation for KS, as reflected in their formal usage described in the KS Tumor Assessment Manual of Procedures. However, acquiring a clear, informative photo is not trivial, since anatomy is 3D and conventional imaging is 2D. The importance of accurate, quantitative 3D information is especially pronounced for the treatment of KS because when a tumor responds positively to treatment, the initial change is usually a flattening of the lesion, without any significant change in the projected 2D area. To evaluate the vertical space, along with other characteristics of a KS lesion, we have created an innovative imaging system, SkinScan3D, utilizing new commercial liquid lens technologies and AI based image analysis software, with strategies borrowed from astronomical imaging techniques previously used on NASA space telescopes. In this study, the investigators will develop and demonstrate a protocol for recording measurable 3D parameters, which may be used in a longitudinal study to rigorously monitor therapeutic responses of KS and statistically compare with that of the conventional AMC criteria.

Study Overview

• Status: Recruiting
• Conditions: Kaposi Sarcoma
• Intervention / Treatment: Device: SkinScan3D camera

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Lee Ratner, M.D., Ph.D.; Phone Number: 314-362-8836; Email: lratner@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Feng Gao, Ph.D.
      • Contact: Lee Ratner, M.D., Ph.D.; Phone Number: 314-362-8836; Email: lratner@wustl.edu
      • Principal Investigator: Lee Ratner, M.D., Ph.D.
      • Sub-Investigator: Thomas Odeny, MBChB, MPH, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will enroll at Siteman Cancer Center at Washington University School of Medicine.

Description

Eligibility Criteria:

• Have been diagnosed with histologically or cytologically proven Kaposi sarcoma (KS).
• Patients may be off treatment or on treatment for their KS.
• Has at least 3 cutaneous Kaposi sarcoma lesions.
• At least 18 years of age.
• Ability to understand and willingness to sign an IRB approved written informed consent document.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort A: No treatment; Consenting and eligible patients will have tumor assessments performed at baseline then up to 12 additional visits (or more if the device cannot collect the data at a visit). These assessments will be done by ruler or calipers, cell phone 2D photographs, and SS3D camera.
Cohort B: Active treatment; Consenting and eligible patients will have tumor assessments performed at baseline then up to 12 additional visits (or more if the device cannot collect the data at a visit). These assessments will be done by ruler or calipers, cell phone 2D photographs, and SS3D camera.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful capture of high-quality 3D images of cutaneous KS lesions	Feasibility is defined as > 90% of lesions captured in the conventional imaging procedures are also seen in the SkinScan3D data, and that unique height and volume data is captured by the SkinScan3D for > 70% of lesions.	Baseline and up to 12 additional visits, each visit will take approximately 30 minutes (estimated to be 12 months)
Time to detect response or failure to treatment (Cohort B only)	Differences between the SkinScan3D and standard 2D in time to detect response or failure to treatment.	Baseline and up to 12 additional visits, each visit will take approximately 30 minutes (estimated to be 12 months)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI); Pensievision
• Investigators: Principal Investigator: Lee Ratner, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Imaging; 3D; Photography; Kaposi
• Additional Relevant MeSH Terms: Neoplasms; Infections; Virus Diseases; Neoplasms by Histologic Type; DNA Virus Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Herpesviridae Infections; Neoplasms, Vascular Tissue; Sarcoma, Kaposi
• Other Study ID Numbers: 202501193; U01CA292765 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No